Some Thoughts on the Use of Predictive Probability in Clinical Trials

Ther Innov Regul Sci. 2023 May;57(3):464-466. doi: 10.1007/s43441-022-00456-3. Epub 2023 Jan 11.

Authors

Affiliations

¹ Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.
² Division of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. xu.yan@fda.hha.gov.

PMID: 36630011
DOI: 10.1007/s43441-022-00456-3

Abstract

In this short note, we express our viewpoint regarding declaring study success based on Bayesian predictive probability of study success.

Keywords: Adaptive design; Bayesian; Clinical trial; Early study success; Predictive probability.

© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.

MeSH terms

Bayes Theorem
Probability
Research Design*